PeriodontitisNCT03588507
Clinical and Radiographic Evaluation of PPF With or Without NCHA Bone in Treatment of Intrabony Defects
A study testing PPF+NCHA bone graft substitute in people with Periodontitis and Periodontal Diseases, run by Cairo University.
Trial summary
This study is meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with papilla preservation flap versus papilla preservation flap alone in the treatment of periodontal intrabony defects. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Periodontal Diseases, Periodontal Pocket
- What is being tested?
- PPF+NCHA bone graft substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Patient consulting in the outpatient clinic.
- Able to tolerate surgical periodontal procedures.
- Patient ready to perform oral hygiene instructions.
- Compliance with the maintenance program.
- Provide informed consent.
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- Accepts the 6 months follow-up period.
- Teeth related criteria:
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra osseous defect ≥ 3mm.
Who cannot join
- Patient-related criteria:
- Medically compromised patients.
- Pregnant or nursing women.
- Uncooperative patients.
- Smokers.
- Teeth related criteria:
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- Teeth with one wall intra-bony defect.
- Teeth with supra-bony defects.
- Teeth with grade II or III mobility.
- Teeth with proximal carious defects or proximal faulty restorations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical and Radiographic Evaluation of Papilla Preservation Flap With or Without Nanocrystalline Hydroxyapatite Bone Graft for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
This study is meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with papilla preservation flap versus papilla preservation flap alone in the treatment of periodontal intrabony defects. Patients will be randomly assigned to either test or control group. The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PPF techniques + Nanocrystalline hydroxyapatite bone graft) and which will receive (PPF techniques only) will be taken.
Read the detailed description
Treatment of intrabony defects has been indicated mainly to decrease the residual probing depths and so improve tooth prognosis. However, the rationale behind periodontal regeneration was to decrease the pocket depth, improve clinical attachment level and achieve bone fill of severely compromised tooth. However, application of all regenerative strategies needed to be protected by stable soft tissues to avoid exposure and bacterial contamination. That's why modified and simplified papilla preservation flap techniques were developed to maintain the primary closure of interdental sites. The modified papilla preservation technique was developed in order to achieve and maintain primary closure of the flap and to increase the ability to create space for regeneration in the interdental area. The modified papilla preservation technique could be successfully applied in sites in which the interdental space width is at least 2 mm at the most coronal portion of the papilla and in conjunction with a variety of regenerative materials as bone grafts. When interdental sites were narrower, a different papilla preservation procedure had been proposed, the simplified papilla preservation flap In the past years, different Alloplastic synthetic bone graft materials had shown clinical acceptance in the treatment of periodontal osseous defects.Recently, it has been claimed that there were promising results from using nano-sized ceramics as a class of bone graft substitutes due to their improved osseointegration properties. That's why a synthetic nanocrystalline hydroxyapeptite bone grafting material has been introduced for the augmentation of intrabony defects. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface.
- Being tested
- PPF+NCHA bone graft substitute
- Keywords
- papilla preservation, modified papilla preservation, simplified papilla preservation, nanocrystalline hydroxyapetite, nanobone graft
- Medical subject headings
- Periodontitis, Periodontal Diseases, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPF+NCHA bone graft substituteCombination product
nanocrystalline hydroxyapatite bone graft is a a newly developed HA containing about 65% water and 35% nanostructured apatite particles. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface .
| Study group | Role | What they receive |
|---|---|---|
| Papilla preservation flap techniques | No intervention | Papilla preservation flap techniques will be conducted to gain access to the intrabony defects. In the narrow interproximal spaces (≤2 mm), incision with the preservation of the buccal papilla according to the simplified papilla preservation technique will be applied. Whereas, in the wide interdental spaces (>2 mm), the modified papilla preservation technique will be applied. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. |
| PPF+NCHA bone graft substitute | Active comparator | intervention: papilla preservation flap techniques + nanocrystalline hydroxyapatite bone graft substitute Same surgical techniques and procedures will be performed. Before suturing the flap, nanocrystalline hydroxyapatite bone graft substitute(Dentaurum, Germany) will be placed within the defect up to the existing level of the alveolar crest and care will be taken not to overfill the defect. The mucoperiosteal flaps will be repositioned and secured in place using non-resorbable # 6-0-suturing material. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. Receives: Combination Product: PPF+NCHA bone graft substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
Measured: 6 months
Secondary outcomes (5)
Probing Depth
Measured from the gingival margin to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
Measured: 6 months
Gingival Recession Depth
Measured from the CEJ to the most apical extension of the gingival margin by William's graduated Periodontal probe in mm
Measured: 6 months
Plaque index
Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
Measured: 6 months
Gingival index
Numerical Scoring system Scores 0,1,2,3 by William's graduated Periodontal probe
Measured: 6 months
Linear bone fill
Measured from the CEJ to the deepest part of the intrabony defect using the linear measurement tool of the Digora software
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa ashraf, Cairo University
- Investigators
- Alaa A Rakha, master, Principal investigator, Cairo UniversityNoha A Ghallab, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588507
- Sponsor's protocol ID
- ppfrct
- Status last verified
- Jul 2018
- First submitted
- 24 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
PubMed 19680697
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Papilla Preservation Flap With or Without Nanocrystalline Hydroxyapatite Bone Graft for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03588507
- Acronym / sponsor ID
- ppfrct
- Keywords
- papilla preservation, modified papilla preservation, simplified papilla preservation, nanocrystalline hydroxyapetite, nanobone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with papilla preservation flap versus papilla preservation flap alone in the treatment of periodontal intrabony defects. Patients will be randomly assigned to either test or control group. The two groups will be equally prepared for both surgical procedures. Then the decision of which group will receive (PPF techniques + Nanocrystalline hydroxyapatite bone graft) and which will receive (PPF techniques only) will be taken.
Detailed description
Treatment of intrabony defects has been indicated mainly to decrease the residual probing depths and so improve tooth prognosis. However, the rationale behind periodontal regeneration was to decrease the pocket depth, improve clinical attachment level and achieve bone fill of severely compromised tooth. However, application of all regenerative strategies needed to be protected by stable soft tissues to avoid exposure and bacterial contamination. That's why modified and simplified papilla preservation flap techniques were developed to maintain the primary closure of interdental sites. The modified papilla preservation technique was developed in order to achieve and maintain primary closure of the flap and to increase the ability to create space for regeneration in the interdental area. The modified papilla preservation technique could be successfully applied in sites in which the interdental space width is at least 2 mm at the most coronal portion of the papilla and in conjunction with a variety of regenerative materials as bone grafts. When interdental sites were narrower, a different papilla preservation procedure had been proposed, the simplified papilla preservation flap In the past years, different Alloplastic synthetic bone graft materials had shown clinical acceptance in the treatment of periodontal osseous defects.Recently, it has been claimed that there were promising results from using nano-sized ceramics as a class of bone graft substitutes due to their improved osseointegration properties. That's why a synthetic nanocrystalline hydroxyapeptite bone grafting material has been introduced for the augmentation of intrabony defects. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papilla preservation flap techniques | No intervention | –Papilla preservation flap techniques will be conducted to gain access to the intrabony defects. In the narrow interproximal spaces (≤2 mm), incision with the preservation of the buccal papilla according to the simplified papilla preservation technique will be applied. Whereas, in the wide interdental spaces (>2 mm), the modified papilla preservation technique will be applied. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. |
| PPF+NCHA bone graft substitute | Active comparator | Combination Product: PPF+NCHA bone graft substituteintervention: papilla preservation flap techniques + nanocrystalline hydroxyapatite bone graft substitute Same surgical techniques and procedures will be performed. Before suturing the flap, nanocrystalline hydroxyapatite bone graft substitute(Dentaurum, Germany) will be placed within the defect up to the existing level of the alveolar crest and care will be taken not to overfill the defect. The mucoperiosteal flaps will be repositioned and secured in place using non-resorbable # 6-0-suturing material. Vertical or horizontal mattress sutures and additional interrupted single sutures will be performed to obtain primary closure of the interdental space. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient-related criteria:
- Mature permanent tooth.
- Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra osseous defect ≥ 3mm.
Key exclusion criteria (10 listed)
- Patient-related criteria:
- Teeth with one wall intra-bony defect.
- Teeth with supra-bony defects.
- Teeth with grade II or III mobility.
- Teeth with proximal carious defects or proximal faulty restorations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPF+NCHA bone graft substitutenanocrystalline hydroxyapatite bone graft is a a newly developed HA containing about 65% water and 35% nanostructured apatite particles. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface . | Combination product | PPF+NCHA bone graft substitute |
Primary outcome
Clinical attachment level
Time frame: 6 months
Measured from the CEJ to the bottom of the gingival sulcus by William's graduated Periodontal probe in mm
5 secondary outcomes
Probing Depth
Time frame: 6 months
Gingival Recession Depth
Time frame: 6 months
Plaque index
Time frame: 6 months
Gingival index
Time frame: 6 months
Linear bone fill
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Results publication: PubMed 19680697Heinz B, Kasaj A, Teich M, Jepsen S. Clinical effects of nanocrystalline hydroxyapatite paste in the treatment of intrabony periodontal defects: a randomized controlled clinical study. Clin Oral Investig. 2010 Oct;14(5):525-31. doi: 10.1007/s00784-009-0325-x. Epub 2009 Aug 13.
- reference link from PubMedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa A Rakha, master principal investigator
Cairo University
Noha A Ghallab, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing PPF+NCHA bone graft substitute in people with Periodontitis and Periodontal Diseases, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa A Rakha, master (00201098797367, dralaaashraf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03588507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.